MAUDE Adverse Event Report: NAKANISHI INC. NSK SGA-E2S; HANDPIECE, ROTARY BONE CUTTING

Model Number SGA-E2S

Device Problem Insufficient Information (3190)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 11/20/2013

Event Type  Injury  

Manufacturer Narrative

Nakanishi inc.As manufacturer of the sgs-e2s dental handpiece is unable to conduct an investigation regarding the device in this event due to: the device in question was not returned to (b)(4), our importer or to nakanishi inc.Directly by the complainant.No serial number was provided by the complainant, so no evaluation of the device dhr could be conducted.Nakanishi conducted a review of the fda maude database and was unable to locate report 9611253-2014-00006 (this report).Nakanishi believes this report to have been submitted previously; however nakanishi is re-submitting this report to ensure that fda has a record of the report in the maude database.Device not returned by complainant.

Event Description

On (b)(6) 2014, (b)(4) a nakanishi inc.Importer received a telephonic complaint of a handpiece allegedly causing a burn to a patient.Complainant only provided the model number to nsk america.The specific serial number of the device involved in this event is unknown.The (b)(4) employee contacted collected the following information from the doctor: handpiece heated up and caused a 2nd degree burn about 1cm area and healing of the wound left a slight scar.Dental procedure being performed was a wisdom tooth extraction.Patient was awake under local anesthetic.Handpiece was sent for service but not sent to (b)(4).Doctor stated reason for delay in reporting was that she was unable to find contact information for (b)(4).(b)(4) checked their internal service records and did not locate any records of them performing any repair activity for this doctor.Handpiece serial number was not known by the doctor and no further record searches could be performed to determine the date of sale of the handpiece to the doctor.(b)(4) sent a follow-up letter requesting additional information and return of the handpiece to dr.(b)(6) on (b)(6) 2014.As of september 3, 2014 (b)(4) has received no response from the complainant.

• Brand Name: NSK SGA-E2S
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: kenneth block ; 800 e campbell rd.; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 5633760
• MDR Text Key: 44476875
• Report Number: 9611253-2014-00006
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/11/2014,07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: SGA-E2S
• Device Catalogue Number: H265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2014
• Distributor Facility Aware Date: 06/30/2014
• Event Location: Other
• Date Report to Manufacturer: 06/30/2014
• Date Manufacturer Received: 06/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 9611253-060818-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 77